Application 018671
- Type
- NDA
- Sponsor
- CARDINAL HEALTH 418
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SODIUM IODIDE I 123 | SODIUM IODIDE I-123 | CAPSULE;ORAL | 100uCi | Yes | Yes |
| 002 | SODIUM IODIDE I 123 | SODIUM IODIDE I-123 | CAPSULE;ORAL | 200uCi | Yes | Yes |
| 003 | SODIUM IODIDE I 123 | SODIUM IODIDE I-123 | CAPSULE;ORAL | 400uCi | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 48815-1001 | Sodium Iodide I 123 | Sodium Iodide I 123 | Cardinal Health 418, Inc | NDA | Current |
| 48815-1002 | Sodium Iodide I 123 | Sodium Iodide I 123 | Cardinal Health 418, Inc | NDA | Current |
Documents
| Document | Title | Submission type | Submission no. | Date | Storage |
|---|
| 33552 | 0 | SUPPL | 16 | 2008-06-18 | Cached in FDA.report object storage |
| 15085 | 0 | SUPPL | 16 | 2008-06-17 | Cached in FDA.report object storage |